Clearance Summary
ElintMAX Respiratory Monitor (ElintMAX Monitor A1) received FDA 510(k) clearance under submission number K260226, sponsored by Amptron Medical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2026-09-16.
- Submission: K260226
- Applicant / Sponsor: Amptron Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1850
- Decision date: 2026-09-16
Classification & Regulation
This clearance is catalogued under FDA product code BZK and 21 CFR 868.1850, within the Anesthesiology review panel as a Class II device.